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First oral targeted theapy for Patients with refractory lung cancer mutations
First oral targeted theapy for Patients with refractory lung cancer mutations. Patients with refractory lung cancer mutations are expected to usher in the first oral targeted therapy
There are many types of lung cancer. Over 80% are non-small cell lung cancer, but some are refractory mutant lung cancers.
Recently, the US FDA announced the approval of a new drug application for oral therapy Mobocertinib (TAK-788) and granted priority review status for the treatment of EGFR exon 20 insertion-positive metastatic non-small cell lung cancer (NSCLC) adult patients who had previously Received platinum-containing chemotherapy.
Mobocertinib is the first oral therapy specifically designed to selectively target EGFR exon 20 insertion mutations. It is expected that the FDA will give an approval on October 26 this year. If approved successfully, it means that such patients are expected to usher in the first oral targeted therapy in half a year.
▌Refractory lung cancer mutations that cannot be ignored
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of all lung cancers.
According to data released by the World Health Organization, there are approximately 2.2 million newly diagnosed lung cancer cases worldwide each year, and the death toll exceeds 1.8 million, making it the world’s highest mortality rate of cancer. In China, the new incidence and death rate of lung cancer ranks first in the world.
Metastatic NSCLC with positive insertion of epidermal growth factor receptor (EGFR) exon 20 accounts for about 1-2% of NSCLC patients. It is a refractory mutation and is more common in Asian populations.
At present, there is no approved targeted therapy for this gene mutation, and TKI treatments that have been approved for marketing provide extremely limited clinical benefits, poor prognosis, and patients urgently need new treatment options.
▌Oral therapy: Mobocertinib
Mobocertinib is an under-research, oral small molecule tyrosine kinase inhibitor (TKI), specifically designed to selectively target EGFR exon 20 insertion mutations.
In April 2020, the drug obtained the breakthrough therapy designation granted by the FDA.
It is worth mentioning that in October of the same year, Mobocertinib was designated as a breakthrough therapy drug by the National Center for Drug Evaluation (CDE) in China for use in EGFR exon 20 insertion mutations that have previously received at least one systemic chemotherapy. Of locally advanced or metastatic NSCLC patients.
Previously, Poziotinib, a broad-spectrum HER inhibitor, was granted Fast Track designation by the FDA for use in previously treated non-small cell lung cancer patients with EGFR/HER2 exon 20 mutations.
In a clinical trial, 91% of patients in the Poziotinib treatment group showed tumor shrinkage.
▌Disease control rate is 78%, continuous relief for one and a half years!
The Phase 1/2 clinical trial aims to evaluate the safety, pharmacokinetics, and anti-tumor activity of the oral drug Mobocertinib in patients with metastatic NSCLC with positive EGFR exon 20 insertion mutations.
The previously published data shows:
◆ Among 114 patients, the Mobocertinib treatment group achieved an objective response rate of 28% and a disease control rate of 78%.
◆ In addition, the drug also showed long-lasting remission, with a median duration of remission of 17.5 months.
Currently, EGFR exon 20 insertion-positive NSCLC patients still face huge challenges. However, the dual-target monoclonal antibody Amivantamab (JNJ-372), HER inhibitor Poziotinib and other research therapies have also given such patients hope for treatment. Once Mobocertinib is approved, it is expected to benefit more patients with refractory lung cancer.
(source:internet, reference only)